Pharmaceutical compounder

ABSTRACT

Information management systems and methods can be used with at least one pharmaceutical compounding device. The systems and methods comprise a controller coupled to the compounding device. A compounding control manager resides on the controller to receive compounding order input and generate control commands to the compounding device based, at least in part, upon the compounding order input. An order process control manager is in data communication with the compounding control manager to communicate compounding order input to the compounding control manager. The order entry process manager includes an order function for receiving entry of compounding order input through a browser-based interface. The browser-based interface can include an order entry workstation separate from the compounding device, or a network of order entry workstations separate from the compounding device, or can reside on the controller.

RELATED APPLICATIONS

This application is a Divisional application of U.S. application Ser.No. 10/335,552, filed Dec. 31, 2002 which claimed the benefit ofpriority of U.S. Provisional Application No. 60/344,869, filed Dec. 31,2001.

FIELD OF THE INVENTION

This invention relates to systems and methods for compounding of liquidsand/or drugs intended to be administered to a human being or an animal.

BACKGROUND OF THE INVENTION

Pharmaceutical compounding involves the transfer of two or more ofindividual prescribed liquids and/or drugs from multiple sourcecontainers into a single collecting container, for the purpose ofadministering the mix of liquids and/or drugs intravenously to anindividual in need. Presently, the pharmaceutical compounding of liquidsand/or drugs takes place primarily at one of three sites. These are: (1)hospital based compounding performed by pharmacists or pharmacytechnicians in the hospital pharmacy; (2) alternate site basedcompounding performed primarily by pharmacists or pharmacy techniciansin the home care company pharmacy; and (3) compounding centers operatedby any one of several major pharmaceutical or hospital supply companies.

The operational and performance demands upon these compounding systemsand methodologies are becoming increasingly more complex andsophisticated, in terms of, e.g., safety, speed, reliability, accuracy,and overall user friendliness and ergonomics. The operational andperformance demands upon these compounding systems and methodologies arealso becoming increasingly more complex and sophisticated with regard tothe management of patient and prescription information, in terms ofproviding an information path that starts with the clinician andfinishes with the final product delivery to the end patient.

SUMMARY OF THE INVENTION

One aspect of the invention provides information management systems andmethods adapted to be used with at least one pharmaceutical compoundingdevice. The systems and methods comprise a controller coupled to thecompounding device. A compounding control manager resides on thecontroller to receive compounding order input and generate controlcommands to the compounding device based, at least in part, upon thecompounding order input. An order process control manager is in datacommunication with the compounding control manager to communicatecompounding order input to the compounding control manager. The orderentry process manager includes an order function for receiving entry ofcompounding order input through a browser-based interface.

The browser-based interface can include an order entry workstationseparate from the compounding device, or a network of order entryworkstations separate from the compounding device, or can reside on thecontroller.

The order entry process manager can include a database function forretaining the compounding order input in memory, a printing function forgenerating printable output, e.g., labeling, based, at least in part,upon the compounding order input, or a report function for generatingreporting output based, at least in part, upon the compounding orderinput.

Another aspect of the invention provides a pharmaceutical compoundingdevice that comprises at least one pump element, a controller coupled tothe pumping element, and a compounding control manager residing on thecontroller to receive compounding order input and generate controlcommands to the pump element based, at least in part, upon thecompounding order input. According to this aspect of the invention, thecompounding control manager includes a verification function thatrequires a prescribed bar code input before generation of the controlcommands. The bar code input can include, e.g., a source solutionidentification, and/or a source solution lot number, and/or a sourcesolution expiration date.

Another aspect of the invention provides an interface for performing apharmaceutical compounding procedure using a compounding device. Theinterface comprises a controller coupled to the compounding device, adisplay screen coupled to the controller, and a compounding controlmanager residing on the controller to receive compounding order inputand generate control commands to the compounding device based, at leastin part, upon the compounding order input. According to this aspect ofthe invention, the compounding control manager includes a graphical userinterface generated on the display screen that includes at least onetouch-screen function for receiving compounding order input. Thetouch-screen function can affect, e.g., the selection of a sourcesolution, or the selection of an amount of liquid to be transferred. Thecompounding control manager can also include a help function executedthrough the graphical user interface, or an informational video executedthrough the graphical user interface.

Another aspect of the invention provides an interface for performing apharmaceutical compounding procedure using a compounding device. Theinterface comprises a controller coupled to the compounding device, adisplay screen coupled to the controller, and a compounding controlmanager residing on the controller to receive compounding order inputand generate control commands to the compounding device based, at leastin part, upon the compounding order input. According to this aspect ofthe invention, the compounding control manager includes at least oneinformational video displayable on the display screen.

Another aspect of the invention provides a pharmaceutical compoundingdevice that comprises a driver and a drive shaft coupled to the driverfor rotation. The drive shaft extends along a first axis. The devicealso includes an idler shaft that extends along a second axis offsetfrom the first axis. A peristaltic pump rotor is carried on the idlershaft. A drive gear is carried on the drive shaft and coupled to theperistaltic pump rotor. A clutch assembly is carried on the drive shaftand coupled to the drive gear. The clutch assembly is operable in afirst mode to disengage the drive gear from the drive shaft and a secondmode to engage the drive gear with the drive shaft. The clutch assemblythereby selectively imparts rotation of the drive shaft to theperistaltic pump rotor.

Another aspect of the invention provides a fluid transfer set. The setcomprises first transfer tubing, second transfer tubing, and a manifoldthat joins the first transfer tubing and second transfer tubing in flowcommunication. A first one way valve is in-line in the first transfertubing to allow fluid flow in the first transfer tubing toward themanifold but not in an opposite direction. The first one-way valve has afirst cracking pressure. A second one way valve is in-line in the secondtransfer tubing to allow fluid flow in the second transfer tubing towardthe manifold but not in an opposite direction. The second one-way valvehas a second cracking pressure different than the first crackingpressure. When used in pharmaceutical compounding, the transfer set canmediate lipid hazing.

Other features and advantages of the inventions are set forth in thefollowing specification and attached drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a pharmaceutical compounding system thatincludes a compounding device that, in use, mixes or compounds two ormore selected liquids and/or drugs intended to be administered to ahuman being or an animal.

FIG. 2A is a view of a disposable transfer set that can be used inassociation with the compounding device shown in FIG. 1.

FIGS. 2B and 2C are enlarged views, partially broken away and insection, of an embodiment of a manifold that the transfer set shown inFIG. 2A can incorporate to mediate against lipid hazing.

FIGS. 2D and 2E are enlarged views, partially broken away and insection, of another embodiment of a manifold that the transfer set shownin FIG. 2A can incorporate to mediate against lipid hazing.

FIG. 2F is a view of a portion of the disposable transfer set shown inFIG. 2A, which includes a transfer tube organizer to facilitate use ofthe transfer set with the compounding device shown in FIG. 1.

FIG. 3 is a perspective view of the system shown in FIG. 1 with thetransfer set shown in FIG. 2A mounted for use on the compounding device.FIG. 4 is a perspective view of the compounding device shown in FIG. 1,with its peristaltic pumping station open for loading a transfer set ofthe type shown in FIG. 2A.

FIG. 5 is a perspective view of a compounding device shown in FIG. 4,with a transfer set mounted in the peristaltic pumping station.

FIG. 6A is a perspective side view of the compounding device shown inFIG. 4 with its exterior case removed to show the peristaltic pumpcomponents and other internal components.

FIG. 6B is an exploded perspective view of the peristaltic pumpcomponents shown in FIG. 6A.

FIG. 7 is a top view of the compounding device shown in FIG. 6A.

FIGS. 8A to 8F are schematic views of alternative configurations oflinked and/or networked systems that incorporate the compounding deviceshown in FIG. 1.

FIGS. 9A to 9W are representative screens of a graphical user interfacethat a compounding control manager function residing on the compoundingdevice shown in FIG. 1 can generate in the process of enabling andcontrolling a compounding procedure.

FIGS. 10A to 10E are system flow charts of representative functionalmodules of an order entry process manager function that, when used inassociation with the compounding control manager function of thecompounding device shown in FIG. 1, provides enhanced compounding orderentry and processing capabilities that can be accessed by browsersinstalled on remote workstations.

FIGS. 11A to 11I are representative screens of a browser-based graphicaluser interface that makes accessible to a remote workstation thefunctional modules of the order entry process manager shown in FIGS. 10Ato 10E.

FIG. 12 is a representative view of labeling that the order entryprocess manager shown in FIGS. 10A to 10E and FIGS. 11A to 11I cangenerate.

FIG. 13 is a schematic view of a controller that the compounding deviceshown in FIG. 1 can incorporate, which can execute the compoundingcontrol manager and order entry process manager functions shown in FIGS.9A to 9W; 10A to 10E; 11A to 11I.

FIG. 14 are representative screens of a training/help video-audiofunction that can be integrated with the compounding control manager ofthe compounding device shown in FIG. 1.

The invention may be embodied in several forms without departing fromits spirit or essential characteristics. The scope of the invention isdefined in the appended claims, rather than in the specific descriptionpreceding them. All embodiments that fall within the meaning and rangeof equivalency of the claims are therefore intended to be embraced bythe claims.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

FIG. 1 shows a pharmaceutical compounding system 10. The system 10 canbe used for mixing or compounding two or more selected liquids and/ordrugs intended to be administered to a human being or an animal. In use,the system 10 serves to transfer two or more of individual prescribedliquids and/or drugs from multiple source containers (e.g., individualvials, bottles, syringes, or bags) into a single collecting container(e.g., a bottle, syringe, or bag), so that the mix of liquids and/ordrugs can be administered (e.g., intravenously) to an individual inneed.

As one example, due to injury, disease, or trauma, a patient may need toreceive all or some of their nutritional requirements intravenously. Inthis situation, the patient will typically receive a basic solutioncontaining a mixture of amino acids, dextrose, and fat emulsions, whichprovide a major portion of the patient's nutritional needs, which iscalled total parenteral nutrition, or, in shorthand, TPN. In thisarrangement, a physician will prescribe a mixture of amino acids,dextrose, and fat emulsions to be administered, as well as the frequencyof administration. To maintain a patient for an extended period of timeon TPN, smaller volumes of additional additives, such as vitamins,minerals, electrolytes, etc., are also prescribed for inclusion in themix. Using the system 10, under the supervision of a pharmacist, theprescription order is entered and individual doses of the prescribedliquids, drugs, and/or additives are accordingly transferred fromseparate individual source containers for mixing in a single containerfor administration to the individual.

There are other environments where the system 10 is well suited for use.For example, in the medical field, the system 10 can be used to compoundliquids and/or drugs in support of chemotherapy, cardioplegia, therapiesinvolving the administration of antibiotics and/or blood productstherapies, and in biotechnology processing, including diagnosticsolution preparation and solution preparation for cellular and molecularprocess development. Furthermore, the system 10 can be used to compoundliquids outside the medical field.

Nevertheless, for the purpose of explaining the features and benefits ofthe system 10, the illustrated embodiment describes use of the system 10in support of TPN.

I. System Overview

The system 10 includes three principal components. These are (i) aliquid transfer set 12 (see FIG. 2A), which, in use, couples a finalsolution container 14 to individual solution source containers 16; (ii)a compounding or solution mixing device 18 (see FIG. 1), which, in use(see FIG. 3), interacts with the transfer set 12 to transfer liquidsfrom the solution source containers 16 into the final solution container14; and (iii) a controller 20 (see FIG. 1) that governs the interactionto perform a compounding or solution mixing procedure prescribed by aphysician, which is typically carried out by a trained clinician at acompounding site under the supervision of a pharmacist.

The compounding device 18 and controller 20 are intended to be durableitems capable of long-term use. In the illustrated embodiment (see FIG.1), the compounding device 18 is mounted inside a housing or case 22,and the controller 20 is mounted, in most part, within a control panel24 mounted to a surface outside the case 22. The case 22 presents acompact footprint, suited for set up and operation upon a tabletop orother relatively small surface. The case 22 and panel 24 can be formedinto a desired configuration, e.g., by molding or forming. The case 22and panel 24 are preferably made from a lightweight, yet durablematerial, e.g., plastic or metal.

The transfer set 12 (FIG. 2A) is intended to be a sterile, single use,disposable item. As FIG. 3 shows, before beginning a given compoundingprocedure, the operator loads the various components of the transfer set12 in association with the device 18.

As illustrated, the device 18 includes a weigh station 26 that, in use,carries the final solution container 14 (as FIG. 3 shows). The weighstation 26 includes a support arm 28, which in the illustratedembodiment, is attached to a side or bottom of the case 22. The weighstation 26 also includes a conventional load cell 30, which suspendsfrom a top of the support arm 28. During compounding, the final solutioncontainer 14 hangs from a hanger H on the load cell 30 (see FIG. 3). Asalso illustrated, the device 18 includes a source solution support frame32. The support frame 32 carries several individual hangers H, which,during compounding, support the individual source containers 16.

As illustrated, the support frame 32 comprises a separate component;however, the support frame 32 can be attached in a suitable manner tothe case 22. Typically, during compounding, the device 18, with sourcecontainers 16 and final container 14, are located within a laminar flowhood in a “clean room” environment.

The transfer set 12 shown in FIG. 2A can in general include lengths ofsource transfer tubing 34, which are joined at one end to a commonjunction or manifold 36. The opposite ends of the source transfer tubing34 each includes a spike 38 or suitable releasable coupling, which canbe inserted in conventional fashion through a diaphragm carried by theassociated source solution container 16, to open flow communicationbetween that source solution container 16 and the respective sourcetransfer tubing 34. A length of final transfer tubing 40 is coupled tothe final solution container 14. The opposite end of the final transfertubing 40 includes a spike 42 or suitable releasable coupling, which canbe inserted into an outlet 44 in the manifold 36, to couple the finalsolution container 14 to the source solution containers 16. The sourcetransfer tubing 34 and the final transfer tubing 40 can be made fromflexible, medical grade plastic material, such as polyvinyl chlorideplasticized with di-2-ethylhexyl-phthalate. One or more of the sourcecontainers 16 or final containers 14 can likewise be made from medicalgrade plastic material selected for inertness and compatibility with theintended source solution. Likewise, one or more of the source or finalcontainers 16 or 14 can be made from glass.

Each source transfer tubing 34 includes an in-line pump segment 46between the spike 38 and the manifold 36. The pump segments 34 can bemade, e.g., from silicone rubber. Each source transfer tubing 34 alsoincludes an in-line, one way valve 48 (e.g., a duckbill, disk, orumbrella valve)—which, in the illustrated embodiment, is carried withinthe manifold 36 (see FIG. 2B)—which permits liquid flow from the sourcecontainers 16 toward the manifold 36, but prevents backflow from themanifold 36 toward any of the source containers 16. Each valve 48 opensin response to forward fluid flow, to allow liquid flow into themanifold 36 and through the spike-receiving outlet 44 (i.e., toward thefinal solution container 14). Each valve 48 closes in response to backflow of liquid in the manifold 36 from the outlet 44.

Each pump segment 46 is designed for use in association with aperistaltic pump rotor. Accordingly, as FIG. 4 shows, the compoundingdevice 18 includes a peristaltic pumping station 50. As FIG. 4 shows,the peristaltic pumping station 50 occupies a pump bay 52 or compartmentformed in the device. As shown, the peristaltic pumping station 50includes an axial array of individual peristaltic pump rotor assemblies54, although non-axial arrays can be used. Furthermore, the pumpingstation 50 can includes multiple side-by-side banks of peristaltic pumprotor assemblies 54.

The peristaltic pumping station 50 includes a door 56, which opens andcloses the pump bay 52. The door 56 opens (as FIG. 4 shows) to allowloading of a selected one of the pump segments 46 in association with aselected one of the peristaltic pump rotor assemblies 54, as FIG. 5shows. The door closes (as FIG. 3 shows) to enclose the peristalticpumping station 50 during operation. Desirably, the controller 20 iscoupled to an electrical interlock 66 (see FIG. 13) to prevent operationof the peristaltic pump rotor assemblies 54 when the door 56 is opened.

The controller 20 executes a compounding protocol or procedure basedupon prescribed data entry orders and preprogrammed pump control rules,which also can include other input from the operator. During operation,the peristaltic pump rotor assemblies 54 are individually, selectivelyoperated in series—or simultaneously, selectively operated inparallel—as dictated by the controller 20, to transfer desired amountsof source solutions from the individual source containers 16 through themanifold 36 and into the final container 14. The load cell 30 is coupledto the controller 20, to gravimetrically monitor the incrementaltransfer of the individual source solutions into the final container 14.The controller 20 monitors incremental changes in weight, which areprocessed according to preprogrammed rule to govern the speed at which agiven peristaltic pump assembly 54 is operated and, ultimately, stoppedwhen the prescribed amount of source solution is delivered.

The controller 20 (see FIG. 13) can comprises a main processing unit(MPU) 58. The MPU 58 comprises a conventional PC that is, in theillustrated embodiment, mounted within the control panel 24, outside thecase 22 of the compounding device 18. Alternatively, the MPU 58 could bemounted within the case 22 of the compounding device 18. The MPU 58 cancomprise one or more conventional microprocessors that support theMicrosoft® Windows® operating environment. The MPU 58 includesconventional RAM 122 and a conventional nonvolatile memory device 74,such as a hard disk drive. The MPU 50 includes an input device 124 toupload programs into the memory device 74, e.g., a CD-reader. In theillustrated embodiment, a compounding control manager function 72resides as process software in the memory device 74 of the MPU 58.

In the illustrated embodiment, the controller 20 also includes asupervisor CPU 126 and peripheral processing unit (PPU) 60. Both the CPU126 and PPU 60 are desirably implemented on a printed circuit board. TheCPU comprises a conventional microprocessor capable of running theuC/OS-II operating system. The PPU is a dedicated microchip PIC, drivenby firmware specific to its processing tasks and control functions. Inthe illustrated embodiment, the CPU 126 and PPU 60 are mounted inside anelectronics bay 62 or compartment with the case 22 of the compoundingdevice 18 (see FIGS. 6A, 6B, and 7). An AC power supply (not shown)supplies electrical power to the CPU 126, PPU 60, and other electricalcomponents of the device 18.

The CPU 126 is coupled via a USB, RS-232, or Ethernet port, or otherconnective means, to the MPU 58 (see FIG. 13). The CPU 126 receiveshigh-level instructions from the MPU 58 generated by the compoundingcontrol manager 72. The PPU 60 (see FIG. 13) is coupled via an RS-232link to the CPU 126. The high-level instructions generated by thecompounding control manager 72 are conveyed by the CPU 126 as mediumlevel commands to the PPU 60. The PPU 60 is connected to varioushardware of the peristaltic pump station 50 and weigh station 26—e.g.,the door interlock 66 (as previously described), a pump motor 64 (seealso FIG. 6A, as will be described later), pump clutches 68 (a will bedescribed later), Hall effect pump rotor sensors 70 (as will also bedescribed later), the load cell 30 (previously described), etc. The PPU60 provides hardware-specific commands, based upon the medium levelcontrol commands generated by the CPU 126, as well as a first level ofsafeguards (e.g., to stop the pump motor 64 if the door 56 is open, aspreviously described). The PPU 60 and CPU 126 communicate with andmonitor each other, to backup individual failures and take correctiveaction.

The compounding control manager 72 function 72 resides on the MPU 58.The compounding control manager 72 includes preprogrammed rules thatprescribe procedures for receiving and manipulating input data,monitoring device status and operating conditions, outputting or storingdata, and commanding operation of the peristaltic pump station 50 toachieve prescribed compounding tasks. The MPU 58 communicates high levelinstructions to the CPU 126 (e.g., the amount of liquid each peristalticpump assembly 54 is to convey), which are created by the compoundingcontrol manager 72 in response to operator input. The CPU 126, in turn,communicates medium level instructions to the PPU 60, which communicatesspecific pump commands to the peristaltic pump assemblies 54 to carryout the pumping instructions, well as receives and evaluates operationalstatus data from sensors and the load cell, to generate closed-loopfeedback control and corresponding alarms. The PPU 60 also relaysoperational status data to the CPU 126, which also evaluates theoperational status data in parallel with the PPU 60. In this respect,the CPU 126 provides a second level of safeguards if an alarm conditionis not detected by the PPU 60 (e.g., to halt pumping ifover-delivery—not otherwise sensed by the PPU 60—is occurring).

In the illustrated embodiment (see FIG. 1), the controller 20 includes adisplay device 76, which is part of the control panel 24, data entrydevices 78 (e.g., a keyboard and a mouse), and a data output station 80(e.g., a printer), which are coupled via appropriate inputs and outputsto the MPU 58. In the illustrated embodiment (see FIG. 1), the displaydevice 76 also desirably serves as another data entry device using,e.g., conventional touch screen methodologies implemented by thecompounding control manager 72 using a Windows®-based operating platformresident in the compounding control manager 72. The combined datadisplay and data entry capabilities that the compounding control manager72 executes in this arrangement provide an interactive user interface onthe display device 76 that, under preprogrammed rules resident in thecompounding control manager 72, accepts data entry and displays for theoperator information prompting or confirming the entered data, as wellas monitored operational status and conditions of the compounding device18. The compounding control manager 72 also provides a third level ofsafeguards by verification of the original order with the actual pumpdelivery results. The display can be in alpha-numeric format and/or asgraphical or pictorial images, as desired. The compounding controlmanager 72 also enables output of selected information to the printer 80in a desired format, e.g., as activity reports. The interactive userinterface of the compounding control manager 72 allows the operator toconveniently enter, view, and assimilate information regarding theoperation of the system 10. Further details of the compounding controlmanager 72 and the touch screen interactive user interface that can beimplemented by the compounding control manager 72 will be describedlater.

As also shown in FIG. 1, the MPU 58 also includes an input for a barcode reader 82 or the like, for scanning information into thecompounding control manager 72. Further details of this aspect of thesystem 10 will be described later.

As FIG. 1 also shows, the MPU 58 also includes input for keyboard andmouse data entry devices 78. These devices 78 allow the operator toenter data for manipulation by the compounding control manager 72 and tointeract with information presented by the display device 76 indifferent ways, and without use of the touch screen data entrycapabilities of the compounding control manager 72. In this arrangement(see FIG. 13), the controller 20 desirably includes an order entryprocess manager 84, which can reside on the memory device 74 of the MPU58 in the control panel 24. The order entry manager 84 makes possibleother forms of interactive data entry and data viewing platforms, aswell as other forms of data output to the printer 80 in a selectedformat, e.g., as labeling for the final solution container 14, as willbe described in greater detail later.

Desirably (as FIG. 13 shows), the order entry process manager 84 can beaccessed by browser software 86 residing on one or more externalmicroprocessors 88 linked to the compounding control manager 72 of thedevice controller 20. In this arrangement, the controller 20 desirablyincludes an RS-232 link or another alternative data communicationconnections (e.g., radio, microwave, infrared, or other electromagneticwave communication systems), to enable electronic or electromagneticdata communication between the compounding control manager 72 andexternal input or output devices (e.g., other data entry workstationsand/or printers), using, e.g., single-station hubless local area networkconnections, multiple-station hub or switch local area networkconnections, multiple-station hub connections with facility networkservers, and/or multiple-station connections through the publicinternet. Conversely, or in addition, multiple compounding devices 18can be linked through their onboard controllers to multiple data entryworkstations or sites. These capabilities of the controller 20 makediverse arrangements of fully networked pharmaceutical compoundingpossible. Further details of these networked forms (e.g., internet,intranet, or loopback) of interactive data entry and data viewingplatforms, that can be accommodated by the controller 20 in associationwith the compounding control manager 72, will be described later.

Upon completing a compounding procedure, the operator seals the inlettubing 40 of the final solution container 14 and detaches the finaltransfer tubing spike 42 from the manifold 36. When there are a seriesof compounding orders that require mixtures of at least some of the samesource solutions, which typically is the case, the operator will proceedto the next compounding order by attaching the spike 42 of the inlettubing 40 of a new final solution container 14 to the manifold 36 andexecuting another compounding procedure. Otherwise, the operator candecouple the source transfer tubing 34 from the source containers 16 andremove the transfer set 12 and source containers 16 from associationwith the device 18. The transfer set 12 can be discarded. Each finalsolution container 14, and its compounded liquid contents, is retainedfor storage, infusion, transfusion, or further processing.

II. Technical Features of the Compounding Device

FIGS. 6A, 6B, and 7 best show the details of construction of arepresentative embodiment of the compounding device 18. As illustrated,the device 18 includes a frame 90 that is divided into the pump bay 52and the electronics bay 62, as previously described. Hardware componentsof the peristaltic pumping station 50 occupy the pump bay 52. Theelectrical components of the pumping station 50 and the load cell 30, aswell as the PPU 60, occupy the electronics bay 62. The case 22 shown,e.g., in FIGS. 4 and 5, encloses the frame 90 and the components itcarries.

A. The Peristaltic Pumping Station

Within the pump bay 52, the peristaltic pumping station 50 includes anarray of peristaltic pump rotor assemblies 54, as already generallydescribed. The number and configuration of peristaltic pump rotorassemblies 54 can vary according to design considerations and thecompounding requirements of the device 18. In the illustrated embodiment(shown in FIG. 4), there are nine peristaltic pump rotor assemblies 54.

As illustrated (see FIGS. 6A and 6B), each peristaltic pump rotorassembly 54 is constructed in the same manner. Each assembly 54 issupported on a bearing plate 92 secured to the frame 90. The bearingplates 92 are arranged sequentially in an axial spaced relationshipalong a drive shaft 94. The drive shaft 94 is coupled at one end to theelectric drive motor 64 (see FIG. 6A) (carried in the electronics bay62) via a drive belt 96 and drive pulley 98. Alternatively, the driveshaft 94 can be coupled directly to the drive motor 64. Operation of thedrive motor 64, which is governed by the controller 20, rotates thedrive shaft 94 at a desired rate of rotation. In a representativeimplementation, the drive motor can rotate the drive shaft 94 atvariable rates. Each pump rotor assembly 54 includes a drive gear 100,which is carried by a bearing 102 on the drive shaft 94. A conventionalelectromagnetic clutch assembly 68 is coupled to each drive gear 100.Each clutch assembly 68 is individually coupled to the controller 20 (asFIG. 13 shows). When actuated by the controller 20, a given clutchassembly 68 frictionally couples the drive gear 100 to the drive shaft94, causing rotation of the drive gear 100. When the clutch assembly 68is not actuated by the controller 20, rotation of the drive shaft 94 isnot imparted to the associated drive gear 100.

A fixed idler shaft 104 extends through the bearing plates 92, spacedfrom and offset from the drive shaft 94. Each pump rotor assembly 54also includes a driven gear 106 carried on a bushing 108 on the idlershaft 104. The driven gears 106 are individually coupled to the drivegears 100, such that rotation of a given drive gear 100 will impartrotation to its respective driven gear 106. In this arrangement, eachpump rotor assembly 54 includes a pump rotor 110 coupled (e.g., by gearattachment screws 112) for rotation with each driven gear 106. Each pumprotor 110 carries an array of pump rollers 114, which, in use, engage anin-line pump segment 46 of the transfer tubing 34.

Actuation of a given clutch assembly 68 by the controller 20 couples theassociated drive gear 100 to the drive shaft 94—to which rotation isimparted by the drive motor 64—which, in turns, imparts rotation throughthe driven gear 106 to the associated pump rotor 110. During rotation ofthe pump rotor 110, the pump rollers 114 engage the associated pumpsegment 46 and convey liquid through the transfer tubing 34 bywell-understood peristaltic pumping action.

Each pump rotor assembly 54 includes a pair of holding brackets 116aligned with the associated pump rotor 110. The holding brackets 116 aresized and configured to releasably mate with mounts 118 (see FIG. 2A)formed on opposite ends of each pump segment 46. The holding brackets116 frictionally engage the pump segment mounts 118, and thereby holdthe pump segments 46 in desired operative association with the pumprollers 114 during use, as FIG. 5 shows.

As will be described in greater detail later, the holding brackets 116of the pump rotor assemblies 54 and pump segment mounts 118 of thetransfer tubing 34 are desirably uniquely coded (e.g., by matchingnumbers and/or by a matching color or the like) to prompt a desiredorder to the mounting of a selected pump segment 46 in relation to aselected pump rotor 110. The unique matching code is also carried by thespike 38 of the associated transfer tubing 34 (e.g., by a numbered,colored tab 120), to prompt a desired coupling of the transfer tubing 34in relation to a selected source container 16. As will be described ingreater detail later, the graphics of the user interface generated bythe compounding control manager 72 desirably incorporates this uniquecode, thereby matching the disposable components of the transfer set 12with the hardware components of the pump station 50, as well as with thedesired software functionality provided by the compounding controlmanager 72.

Desirably, the unique matching code includes bar-code indicia, e.g., oneor two-dimensional bar code. In this arrangement, the compoundingcontrol manager 72 can require the operator to perform the physical actof scanning in bar code indicia on a solution container and on thetransfer set, to eliminate potential error sources prior to compounding.This marriage between software, hardware, and disposable componentsminimizes sources of compounding errors due to human error.

As shown in FIG. 2F, the transfer set 12 can also include a tubingorganizer 128, which comprises a molded or fabricated strip of plasticsized and configured to capture, as a unit, all the transfer tubing 34between the pump segments 46 and the spikes 38 in a desired order. Inthis arrangement, the organizer 128 requires the operator to mount thepump segments 46 as a unit to the holding brackets 116, with the orderof the transfer tubing 24 with respect to the pump rotor assemblies 54preordained by the organizer 128. The organizer 128 further assures thatthe transfer tubing 34 is loaded in a desired order on the compoundingdevice 18.

The system 10 makes possible systematic process control at every stageof the compounding process, starting at the physician order point andcontinuing through compounding and final product delivery and receipt.As above described, orders can be received from the patient site viahospital based electric ordering systems. Upon the electronic receipt ofdata, such data can be entered or transmitted electronically into thecompounding control manager 72. Final solution containers 14 can belabeled automatically as the step preceding the compounding process. Thecompounding process can thereafter be controlled and verified throughlabeling on the final solution container 14 in combination with sourcecontainer labeling and bar coding.

B. Pump Control Criteria

As has been generally described, and as will be described later ingreater detail, a desired compounding order is entered by an operator,and the compounding control manager 72 in the MPU 58 of the controlpanel 24 executes the compounding order. Typically, the compoundingorder identifies the source solutions and the amounts of each sourcesolution (by weight or volume) that are to be mixed in the finalsolution. The compounding control manager 72 can operate the individualpump rotor assemblies 54 (through the PPU 60 in the compounding device18) in a serial compounding mode, i.e., operating a first pump rotorassembly 54 to convey the desired amount of a first source solution intothe final container 14, then next operating a second pump rotor assembly54 to convey the desired amount of a second source solution into thefinal container 14, and so on until the desired amount of each sourcesolution has been delivered to comprise the desired mixture.

In controlling the individual pump rotor assemblies 54, thepreprogrammed rules of the compounding control manager 72 desirably takeinto account pre-established delivery accuracy criteria. The criteriacan vary according to the compounding tasks to be accomplished. Forexample, for TPN, delivery accuracy criteria can be established of ±5%,or better, for any ingredient of 0.2 mL or more. A delivery accuracycriteria of +5%/−0% could be established to eliminate the possibility ofunderfills.

The preprogrammed rules of the compounding control manager 72 alsodesirably include a delivery time criteria that takes into account thedelivery volume. Keeping absolute errors as small as possible ismandated at smaller delivery volumes to achieve a system deliveryaccuracy goal of ±5% or better. Such smaller absolute delivery errorsrequire the compounding control manager 72 to incorporate tighterprocess control, which, for smaller delivery volumes, can result inlonger delivery times per mL of delivery. However, larger absoluteerrors are acceptable at larger delivery volumes to achieve a systemdelivery accuracy goal of ±5% or better. For example, a 1% error on a 10mL delivery is 0.1 mL. The same 1% error on a 1000 mL delivery is 10 mL.Thus, the compounding control manager 72 can institute different processcontrol for larger volumes, which, for larger delivery volumes, canresult in a faster delivery times per mL of delivery.

The compounding control manager 72 can also accommodate parallelprocessing of the same source solution. For example, if the same sourcesolution is present on two pump rotor assemblies 54, both sourcesolutions can be pumped in parallel (at the same time) to shortenoverall delivery time. Thus, if it takes two minutes to fill a singlecontainer using serial compounding (i.e., one solution after the other),it is expected that parallel compounding can potentially reduce thistime requirement down to one minute, depending upon the solutioncomponents that comprise the final product.

The preprogrammed rules of the compounding control manager 72 institutedesirable closed-loop control of the pump drive motor 64. The close-loopcontrol desirably implement convention proportional-integral-derivative(PID) control schemes to control pump speed to achieve a desired targetdelivery. The PID control schemes generate pump correction commands thattake into account not only the absolute difference between the presentdelivery amount and the target amount, but also the how quickly theabsolute difference is changing over time. The control schemes can use apurely mathematical PID model, or they can incorporate “fuzzy logic”techniques, making use of estimations and interpolations to determinehow to adjust the motor speed to obtain the desired flow rate. Use offuzzy logic techniques permit a motor speed control function without useof multiply and divide instructions, thereby minimizing processingcomplexity.

In one representative implementation, the compounding control manager 72conducts a high speed flow rate control regime until the absolutedifference between the volume delivered and the target approaches apreset amount. At this “slow down” point, the compounding controlmanager 72 ramp-downs the flow rate and conducts a low speed flow ratecontrol regime. During this regime, the correction commands becomesuccessively smaller as the difference between the volume delivered andthe target diminishes. The rate of the flow rate reduction during thisregime can be linear or non-linear, and the slope of the non-linearreduction can be either concave, or convex, or a combination thereof.

In a desired implementation, the compounding control manager 72 steps orpulses the respective pump rotor assembly as the target volume isapproached. In this arrangement, the PPU 60 can communicate with rotorrotation sensors 70, so that a rotor revolution can be correlated with anumber of incrementally sensed steps, which, in turn, can be correlatedwith incremental degrees of rotor rotation—e.g., one full revolution(360 degrees) equals five hundred incrementally sensed steps, so eachincrementally sensed step equals 0.72 degrees of rotation. In this way,the PPU 60 can generate very precise pump commands in terms of smallincremental units of pump rotor rotation when the target volume isapproached, to prevent an overfill.

III. Technical Features of the Transfer Set

As before described, for a typical compounding session, there areusually a series of compounding orders that require mixtures of at leastsome of the same source solutions. In this arrangement, an operator willrepeatedly exchange final solution containers 14 with the same manifold36.

In these circumstances, a compounding order that requires a fat emulsionas a source solution can leave a fat emulsion residue in the manifold36. This residue left in the manifold 36, although small in volume, canbe introduced into the final solution container 14 of a subsequentcompounding order, which may not specify a fat emulsion. The unintendedresidue causes what is generally called “lipid hazing” in the finalsolution container 14 of a compounding order that is supposed to be freeof a fat emulsion.

To minimize the lipid hazing effect, in FIG. 2B, there is one transfertubing 34′ that is intended, during use, to be dedicated to theconveyance of a fat emulsion. As before explained, a unique codingarrangement, coupled with required bar code scanning, can beincorporated to assure that this transfer tubing 34′ is dedicated duringuse to the conveyance of fat emulsion from a source container. Duringcompounding, fat emulsion is conveyed into the final solution container14 in advance of the other source solutions. Thus, the compounding ofother source solutions after the fat emulsion serves to flush residualfat emulsion from the manifold 36 and into the final solution container14.

Following compounding, when the spike 42 is withdrawn from the outlet44, a temporary vacuum is created within the manifold 36. The valves 48can open in response to the temporary vacuum created by withdrawal ofthe spike 42 from the outlet 44, drawing a small bolus of sourcesolutions into the manifold 36. A residue of fat emulsion can beincluded in this bolus.

In the illustrated arrangement, the valve 48′ in the manifold 36 that isin-line with the fat emulsion transfer tubing 34′ is sized andconfigured to have a valve opening or “cracking” pressure that isgreater than the valve opening or cracking pressure of the other valves48 in the manifold 36, which are in-line with transfer tubing 34 that isnot coupled to a fat emulsion source container. The greater crackingpressure of the valve 48′ that is in-line with the fat emulsion transfertubing 34′ is selected to keep the valve 48′ closed when the spike 42 iswithdrawn from the outlet 44.

In use (as FIG. 2C shows), when a spike 42 is withdrawn from the outlet44, due to the lesser cracking pressures of the valves 48 that are notin-line with the fat emulsion transfer tubing 34′, these valves 48 canopen in response to the temporary vacuum created by withdrawal of thespike 42 from the outlet 44. However, due to the greater crackingpressure of the valve 48′ that is in-line with the fat emulsion transfertubing 34′, the valve 48′ remains closed when the spike 42 is withdrawnfrom the outlet 44. Thus, as the spike 42 is withdrawn and the temporaryvacuum is created within the manifold 36, the small bolus of sourcesolutions from all the source containers that may be drawn into themanifold 36 will not include the fat emulsion. Thus, a residue of fatemulsion is prevented from entering the manifold 36 when the finalsolution container 14 is exchanged.

In an alternative arrangement (see FIGS. 2D and 2E), the peristalticpump rotor assembly 54′ serving the one transfer tubing 34′ dedicated tothe conveyance of fat emulsion can be capable of reverse rotation underthe direction of the controller 20. Reverse rotation creates a negativepressure and draws the in-line valve 48′ closed. In this arrangement,the controller 20 commands reverse rotation of the fat emulsion pumpassembly 54′ prior to the operator removing the spike 42 from the outlet44. As FIG. 2E shows, removal of the spike 42 can open the valves 48,except the valve 48′ in the fat emulsion tubing 34′, which remainsclosed due to the counterforce of negative pump pressure. As beforedescribed, as the spike 42 is removed, a bolus of source solutions fromall the source containers can be drawn into the manifold 36, except forthe fat emulsion.

The vacuum created by removal of the spike 42 can be augmented bypulsing the other peristaltic pump rotor assemblies 54 in a forwarddirection as the spike 42 is withdrawn. In this arrangement, thecracking pressure of the valve 48′ serving the fat emulsion transfertubing 34′ need not be different that the cracking pressure of the othervalves 48.

IV. Technical Features of the Controller

A. The Compounding Control Manager

The compounding control manager 72 resides in the MPU 58 in the controlpanel 24. The compounding control manager 72 allows a clinician toenter, view, adjust and offload information pertaining to a givencompounding protocol.

In general, the compounding control manager 72 is the program languagethat provides the operator with real time feedback and interaction withthe compounding device through graphic user interface (GUI) elements.The GUI elements, created in a Windows®-based graphical format, displaythe various inputs and outputs generated by the compounding controlmanager 72 and allow the user to input and adjust the information usedby the compounding control manager 72 to operate the compounding device18.

To develop the GUI elements, the compounding control manager 72 canutilize certain third party, off-the-shelf components and tools. Oncedeveloped, the compounding control manager 72 can reside as a standardwindow-based software program on a memory device.

FIGS. 9A to 9W are a walk-through of display screens generated by arepresentative embodiment of the compounding control manager 72, whichdemonstrate various features of the compounding control manager 72.

After an initial start-up mode of software initialization, a main workarea is created on the display device 76, which initially opens a log-inscreen 200 (FIG. 9A). The log-in screen 200 prompts the operator toidentify themself, either by using the bar code scanner to scan anoperator badge number, or by entry of a badge number or other selectedform of identification on the graphical touch screen entry pad. Thisidentification procedure is required for logging-in and/or assessing theoperator's level of security clearance. Desirably, a systemadministrator would have previously established a list of authorizedusers, against which the sign-in data is compared.

Once an authorized identification is entered, the log-in screen 200 isreplaced by a main screen 202 (FIG. 9B). The main screen 202 displayssequentially numbered pump station data fields 204 204. The pump stationdata fields 204 are desirably numbered according to the left to rightplacement of the peristaltic pump rotor assemblies 54 in the compoundingdevice. The numbers are also desirably color-coded according to thecolor code assigned to the peristaltic pump rotor assemblies 54 in thecompounding device 18, as previously described.

Each pump station data field 204 includes a solution field 206 for theoperator to identify what solution is to be delivered, as well as anamount field 208 to identify how much of that solution is to bedelivered. The solution field 206 includes a touch button 210 thatprompts TOUCH TO PROGRAM STATION. Touching the prompt button 210 allowsto operator to enter data in the solution and amount fields 206 and 208required by the compounding control manager 72.

Touching the prompt button 210 first opens a solution programming box212 (FIG. 9C). The solution programming box 212 displays within the mainscreen 202 an array of touch buttons that either contain a specificidentification of a solution type—e.g., DEX (dextrose); AMINO (aminoacid); LIPID (fat emulsion); LYTES (electrolytes)—or allow the operatorto specify another solution type (OTHER), or ask for a list of availablesolutions (LIST). Desirably, a system administrator would havepreviously established a list of solutions, using the OPTIONS MENU touchbutton 214 on the main screen 202, as will be described later. Othertouch buttons in the solution programming box allow the operator toscroll through a list of solutions (PREVIOUS SOLUTION, NEXT SOLUTION).Another button (OK) allows for a verification of the identified solutionand entry of that solution in the solution field 206, or an exit button(CANCEL) that closes the solution programming box 212 with no data entryin the solution field 206. Selection of a specific solution type button(e.g., DEX) (see FIG. 9D) either enters the only solution of its type onthe list (i.e., Dextrose 70%), or, if there are various selections to bemade (e.g., by selecting AMINO), displays a solution listing box 216 forthat solution type (see FIG. 9E), from which the operator selects bytouch.

Once the solution type has been selected, the operator selects the OKbutton on the solution programming box 212, and the solution typeappears (see FIG. 9F) in the solution field 206 of the pump station datafield 204. An amount programming box 218 is also opened (FIG. 9F), whichreplaces the solution programming box 212. The amount programming box218 comprises a graphical numeric keypad, by which the operator canenter an amount expressed in a selected unit which is to be transferredby the selected pump station from the source solution container into thefinal container (e.g., volume, expressed in mL). The unit for the amountcan also be specified by use of the DOSE CALCULATOR touch button 220.Once the numeric amount is entered, pressing the ENTER touch button inthe amount programming box 218 enters the entered amount in the amountfield 208 of the pump station data field 204 (see FIG. 9F), and theamount programming box 218 closes.

The station control box 222 (FIG. 9G) can also be optionally selected bypressing the station number identification icon 224. The station controlbox 222 requires that the transfer of the solution identified in thesolution field 206 be confirmed by the operator pressing the CONFIRMSOLUTION touch button 226. Pressing the CONFIRM SOLUTION touch button226 opens a solution confirmation box 228 (FIG. 9H). The operator isprompted to scan a bar code on the source solution container (using thebar scanner input device 82). This bar code identifies, e.g., thesolution type, the lot number of the solution, and its expiration date.By scanning the bar code, the compounding control manager 72 links thisinformation to a specific compounding order for verification andsolution tracking purposes. Furthermore, the compounding control manager72 can implement expiration date control, locking out the use of expiredsolutions. The integration of the bar code scanning function with thecompounding control manager 72 integrates lot number and expiration datetracking and/or verification to the operation of the compounding device18.

The operator is also prompted to visually assure that the transfertubing 34 having the unique coding corresponding to the pump stationnumber is coupled to the source container from which the bar code isscanned, as well as scan the bar code component of the unique code onthe transfer tubing 24 for that pump station. As confirmation of thecorrect source solution container 15 and transfer tubing 24 is made bythe operator by scanning bar codes, information in the solutionconfirmation box 228 is updated (see FIG. 9I). After full confirmationis accomplished, the operator can press an OK touch button in thesolution confirmation box 228.

The solution flush box 230(see FIG. 9J) can also be optionally selectedby pressing the FLUSH station control button on the station control box222 (see FIG. 9G). The solution flush box 230 includes touch buttonsthat prompt the operator to conduct a SHORT FLUSH (e.g., 2 seconds) or aLONG FLUSH (e.g., 5 seconds), during which time the compounding controlmanager 72 operates the corresponding peristaltic pump rotor assembly 54for the selected pump station. The load cell 30 monitors for weightchanges, indicating entry of solution into the final container 14, toverify (if desired) that flow communication exists between the sourcesolution container 16 and the final container 14. The solution flush box230 indicates completion of the flush (see FIG. 9K), and the operator isprompted to by an EXIT touch button to return to the main screen 202.Flush is not required prior to the start of compounding, but isavailable as an optional set up step.

The operator is prompted to follow the above prescribed sequence foreach source solution and each pump station, until programming iscomplete. FIG. 9L shows the main screen 202 after (i) the operator hasprogrammed the compounding control manager 72 to mix 137 mL of 70%dextrose (pump station 1), 54 mL of 15% novamine (pump station 2), 77 mLof 10% Travasol (pump station 3), and 216 mL of sterile water (pumpstation 9) from source solution containers into the final container, and(ii) the operator has also verified for each pump station that theproper source solution and transfer tubing set up are present. As FIG.9L shows, the main screen 202 lists the solutions and amounts in therespective fields 206 and 208 of each pump station box 204 and, further,prompts the operator to press a highlighted START touch button 232. Uponselection of the START touch button, compounding immediately commencesunder the control of the compounding control manager 72. If one or moreof the source solutions have not been confirmed at the time the operatorpresses the START button 232, the compounding control manager 72 willautomatically prompt the operator to confirm each remaining sourcesolution before compounding is allowed to begin. The START touch button232 is not enabled by the compounding control manager 72 until allrequired preliminary steps have been satisfactorily completed.

Alternatively, the operator can select an AUTO PGM touch button 232 onthe main screen 202 (see FIG. 9L). This opens a queue selection screen236 (FIG. 9P), which displays a list of preprogrammed schedule queuesestablished by the system administrator. The operator selects thedesired queue and presses the ENTER touch button on the queue selectionscreen 336. The compounding control manager 72 holds the order queuelist in memory, and the main screen 202 (see FIG. 9Q) allows theoperator to view the current order queue list, one order at a time, in aqueue box 238. In this arrangement, the operator selects the order fromthe programmed order queue list on the main screen 202, and then startscompounding. Alternatively, the operator can scan a bar code on a finalsolution container to be compounded. The compounding control manager 72uploads and presents the compounding order for that final container.

As compounding proceeds, the compounding control manager 72 updates thenumber TOTAL DELIVERED field 240 (by incrementing up) and amount field208 (by incrementing up) of the respective pump station field 204 of themain screen 202 (FIG. 9M), to indicate the series transfer of liquidfrom the several source containers 16 into the final container 14. InFIG. 9M, pump stations 1, 2, and 3 have been programmed. Station 1 hascompleted its pumping (having delivered the desired 138 mL. Station 3has begun to pump (having pumped 38 mL). Station 9 is waiting to begin.The TOTAL DELIVERED field 240 shows 176 mL, which is the current sum ofamounts pumped by pump stations 1, 2, and 3. The PUMPING icon 242 isilluminated to indicate that compounding is proceeding. The operatorcan, if desired, terminate compounding by pressing the illuminated STOPtouch button 244.

If, during the course of compounding, the load cell 30 indicates thatthere is no liquid transfer into the final container 14, the compoundingcontrol manager 72 generates a pumping alarm. The compounding controlmanager 72 interrupts the compounding procedure when this alarmcondition occurs. The compounding control manager 72 opens a pumpingalarm screen 246 (FIG. 9N). The INTERRUPTED icon 248 is also illuminatedto indicate that compounding is not proceeding. An information field 250displays information pertaining to the alarm condition. The informationfield 250 prompts the operator to take corrective action and, bypressing a RESUME touch button 252, to commence compounding once again.

When compounding is complete, the compounding control manager 72displays a COMPLETE message in the information field 250 (see FIG. 90)and prompts the operator to remove the final container 14.

The operator can then reprogram the compounding control manager 72 tocarry out another compounding regime by following the above sequences ofsteps.

There are other graphical buttons on the main screen 202 (see FIG. 9A),which may be used to carry out various support functions. For example,by pressing the OPTIONS MENU touch button 214, the options menu screen(FIG. 9R) is displayed. The option menu screen prompts the operator toselect among a-list of administrative functions that, in the illustratedembodiment, include REPEAT LAST ORDER, ORDER HISTORY, SETTINGS ANDDIAGNOSTICS, and SIGN OFF. Pressing the REPEAT LAST ORDER buttonautomatically configures the compounding control manger to compoundaccording to the most recent order. Pressing the ORDER HISTORY buttondisplays an order history screen (FIG. 9S), that lists the compoundingorders that have been executed by the compounding control manager 72.These compounding orders are maintained in memory by the compoundingcontrol manager 72. Pressing the SETTINGS AND DIAGNOSTICS buttondisplays the settings and diagnostic screen 260 (FIG. 9T) that displaysadditional administrative functions that the system administrator canperform, such as establishing the list of available source solutions forthe solution programming box 212 (FIGS. 9D and 9E), previouslydiscussed. Other additional administrative functions can also beaccessed through this screen. Pressing the SIGN OFF button displays afresh log-in screen, and the compounding control manager 72 awaits a neworder sequence from an operator.

In the illustrated embodiment, the main screen 202 also includes aCALIBRATE SCALE touch button 262 (see FIG. 9A). When pressed, the button262 opens an instruction screen (FIG. 9W), that leads the operatorthrough a sequence of steps that calibrate the load cell.

Also displayed on the main screen 202 is a HELP icon 264 (identified bya question mark—?). Pressing the HELP icon 264 on the main screen 202opens a main screen help screen 266 (FIG. 9U), which displays a list ofavailable help topics pertaining to the compounding control manager 72and operation of the compounding device 18 in general. Desirably, a HELPicon 264 is also present on every other functional screen or boxgenerated by the compounding control manager 72 (see, e.g., FIGS. 9A,9E, 9H, 9P). Pressing the HELP icon 264 on any given screen opens acontext sensitive help screen, which provides guidance pertaining to theparticular function that the given screen performs. For example, FIG. 9Vshows a context sensitive help screen 268 that opens when the HELP icon264 on the pump alarm screen 246 (FIG. 9N) is pressed. As can be seen,the context specific help topic is NO SOLUTION FLOW ALARM, and thescreen provides instructions for correcting the alarm condition.

In a desired implementation, the compounding control manager 72incorporates within its preprogrammed structure an integrated selectionof training and/or help video files, e.g., in MPEG format. Theintegrated training and/or help video files contain formatted pre-tapedvideo footage and streaming audio. When presented by the compoundingcontrol manager 72 on the display screen 76, the files communicateinformation to the operator in a direct visual and audible way. Thisplatform of communication, which forms an integrated part of thecompounding control manager 72, provides the operator direct, real timeaccess to context specific information in an effective, first person,visual and audible format, eliminating the need to resort to offlinetraining manuals or separate CD's.

In a representative implementation, pressing the HELP icon 264 on themain screen 202 opens a main screen video training/help screen 270 (FIG.14A). The screen 270 displays a list of available training/help topicspertaining to the compounding control manager 72 and operation of thecompounding device 18 in general. The screen incorporates 270 a MPEGviewing area 272, in which the training and/or help video files in thecompounding control manager 72 are displayed. Selecting aninstruction/help topic runs the associated MPEG file.

As an example, FIGS. 14B(1) to 14B(8) show representative screencaptures from a training/help video for “Programming the Compounder.”The training/help video, with associated streaming sound file, walk anoperator through the steps of entering a compounding order using thegraphical user interface of the compounding control manager 72. Thesesteps have been previously described, with reference to FIGS. 9B to 9F.The training/help video explain that the first step is to identify thesource solution (FIG. 14B(2), and then proceed (FIG. 14B(3), by visualand audible instructions, the procedure for using the SolutionProgramming Box 212 (previously described in the context of FIGS. 9C and9D). The training/help video then explain that the next step is todetermine the solution volume (FIG. 14B(4), and then proceed (FIGS.14B(5)to 14B(7), by visual and audible instructions, the procedure forusing the Amount Programming Box 218 (previously described in thecontext of FIG. 9F). The training/help video concludes (FIG. 14B(8)) bycongratulating the operator for successfully accomplishing theprogramming procedure.

As can by now be appreciated, the compounding control manager 72 servesto generate an interactive user interface that presents as muchinformation/control on one screen as possible without making the screentoo busy. Among its features are (i) to minimize user entry errors bymaking their entry points very focused and utilizing large display andkeypad areas; (ii) to minimize keystrokes for the experienced user;(iii) to provide as much help as possible for the inexperienced user;and (iv) to minimize calls to service by making “smart help” available.

The compounding control manager 72 makes possible the operation of agravimetric compounding device 18 under direct software process control,while utilizing bar-codes as a process quality control mechanism.

B. The Order Entry Process Manager

The order entry process manager 84 can be installed on the MPU 58 of thecontroller 20 and/or on another workstation linked to the controller 20.The order entry process manager 84 provides an array of enhanced orderentry functions for the compounding control manager 72. The order entryprocess manager 84 also provides -an information management function andlabel printing function, that make possible simplified and consolidatedorder data record storage and control on a patient-by-patient basis.This function is integrated with the communication of the order data tothe compounding control manager 72 of a compounding device 18, tothereby facilitate set-up, operation, and management of an overallcompounding system in a reliable fashion that minimizes error. The orderentry process manager 84 makes possible a centralized or distributedorder data entry, order data storage, order data manipulation, and orderdata communication system.

The order entry process manager 84 desirably receives data input throughkeyboard/mouse devices 78, and provides data output either through thedisplay screen 76 of the control panel 24 (as shown in FIG. 8A), or aseparate, dedicated display device 300 (as shown in FIGS. 8B to 8F). Theorder entry process manager 84 also is desirably linked to a printer302, for providing reports and labeling in paper form.

The order entry process manager 84 can be developed to generate its ownproprietary user interface (like the compounding control manager 72).Desirably, however, the order entry process manager 84 is developed in agraphics-based environment (e.g., Windows®, Linux®, etc.) using, e.g.,an Apache® or Java® Operating Environment that can be used inassociation with conventional web-server or browser software 86, such asMicrosoft® Internet Explorer, Netscape® Navigator, or an equivalentpublic accessible browser. In this arrangement, the order entry processmanager 84 desirably comprises the program language that provides theoperator with real time feedback and interaction with the controller 20of the compounding device through browser-based graphic user interface(GUI) elements. The browser-based GUI elements allow an operator toinput and adjust the information used by the compounding control manager72 to operate the compounding device. This makes possible the linkage ofthe proprietary compounding control manager 72 of the compounding deviceto one, several, or an entire network of conventional browser data entryand output platforms, which can comprise a single local site or anetwork of remote sites. Implemented in this manner, the order entryprocess manager 84 and browser software 86 make fully networkedcompounding possible. Furthermore, the order entry process manager 84makes possible a network appliance function, whereby all an authorizedoperator has to do is couple a browser to the MPU 58 of the compoundingdevice 18 to be able to control the compounding device 18. The networkappliance function significantly enhances the usability and flexibilityof the compounding device 18.

To develop the browser-based GUI elements, the order entry processmanager 84 utilizes certain third party, off-the-shelf components andtools, available in e.g., Apache® or Java® Operating Environments. Oncedeveloped, the order entry process manager 84 can reside as a softwareprogram on a memory device. The order entry process manager 84 can beaccessed by a laptop or desktop workstation computer, PDA device, or anyother device that can run a browser, to provide different order entryplatforms.

C. Associations with the Compounding Control Manager

The order entry process manager 84 and browser software 86 accommodatediversely different associations with the compounding control manager 72installed on the controller 20 of the compounding device 18.

In a basic form (see FIG. 8A), the order entry process manager 84 andbrowser software can be installed in the MPU 58 in the control panel 24of the compounding device 18, to constitute a single control panelconfiguration. In this arrangement, the display device 76 on the controlpanel 24 supports the browser-based interface of the order entry processmanager 84 for order entry to the compounding device and label printing,as well as supporting the proprietary touch screen interface of thecompounding control manager 72 during operation of the compoundingdevice.

In another arrangement (see FIG. 8B), the browser software 86 can beinstalled on a data entry workstation 304 positioned in the samefacility as the compounding device 18. The data entry workstation 304can be placed near the compounding device 18, or it can be physicallyseparated from the compounding device within the facility. In thisarrangement, the browser software 86 of the data entry workstation 304is linked, e.g., via a hubless local area network connection to theorder entry process manager 84 residing in the MPU 58 in the controlpanel 24 of the compounding device 18, to constitute a single data entrystation configuration. In this arrangement, the display device 300 ofthe data entry workstation 304 supports the browser-based interface ofthe order entry process manager 84 for order entry to the compoundingdevice and label printing. The display device 76 of the control panel 24supports the proprietary touch screen interface of the compoundingcontrol manager 72 during operation of the compounding device 18.

In another arrangement (see FIG. 8C), the browser software 86 can beinstalled on several data entry workstations 304 positioned in the samefacility as the compounding device 18. The browser software 86 of thedata entry workstations 304 can be linked, e.g., via a hub 306 or switchas a local area network to the order entry process manager 84 residingin the MPU 58 in the control panel 24 of the compounding device 18, toconstitute a multiple data entry station configuration. In thisarrangement, the display device 300 of each data entry workstation 304supports the browser-based interface of the order entry process manager84 for order entry to the compounding device 18 and label printing bythe printer 302. A single compounding device 18 can thereby be linked toseveral order entry workstations 304. The display device 76 on thecontrol panel 24 of the compounding device 18 supports the proprietarytouch screen interface of the compounding control manager 72 duringoperation of the compounding device.

In another arrangement (see FIG. 8D), the browser software 86 can beinstalled on several data entry workstations 304 positioned in the samefacility as several compounding devices 18. The browser software 86 ofthe data entry workstations 304 can be linked, e.g., via a server 308 toform an intranet facility network 310, and the order entry processmanager 84 residing in the MPU's 58 in the control panels 24 of theseveral compounding devices 18 can be linked to the server 308 via a hub312, to constitute a fully networked data entry, multiple compoundingstation configuration. In this arrangement, the display device 300 ofeach data entry workstation 304 supports the browser-based interface ofthe order entry process manager 84 for order entry to the compoundingdevice 18 and label printing by the printer 302. Multiple compoundingdevices 18 can thereby be linked to multiple order entry workstations304. The display device 76 in the control panel 24 of each compoundingdevice 18 supports the proprietary touch screen interface of thecompounding control manager 72 during operation of the respectivecompounding device. As shown in FIG. 8D, the browser software can beinstalled in a PDA device 314, or any other device that can run abrowser, to provide different order entry platforms.

In another arrangement (see FIG. 8E), the browser software 86 can beinstalled on one or more data entry workstations 304 positioned in adata entry facility 316 that is remote to another facility 318 where oneor more compounding devices 18 are located. The browser software 86 onone or more data entry workstations 304 at the remote data entryfacility 316 can be linked to the order entry process manager 84residing in the MPU(s) 58 in the control panel(s) 24 of the compoundingdevice(s) 18 at the remote compounding facility 318 via the publicinternet 320. Of course, other forms of remote linkage can be used. Thebrowser software 56 can be installed, alone or with the installation onthe remote workstations 304, on one or more data entry workstations 304at the local compounding facility 318, and also linked to the orderentry process manager 84 in the MPU(s) 58 in the control panel(s) 24 ofthe compounding device(s) 18 via the public internet 320. If thefacilities 316 and 318 are part of a common operating entity, the orderentry process manager 84 and browser software 56 can be installed on adata collection/administration workstation 304 positioned in a datacenter facility 322 that is remote to both the data entry andcompounding facilities 316 and 322. The data center 322 maintains aninformation data base 324 of patient information and compoundingresources for the compounding facility 318, and also be linked to thedata entry facility 316 and the compounding facility 318 via the publicinternet 320.

In a variation to the arrangement shown in FIG. 8E (see FIG. 8F), a hostdata entry service facility 326, where the order entry process manager84 is installed, can be coupled via the public internet 320 to one ormore remote data entry facilities 328A, 328B, 328C, 328D. The host dataentry service facility 326 can also be linked via a virtual privatenetwork 328 through the public internet to a remote compounding facility330, where the compounding control manager 72 is installed in the MPU 58in the control panel 24 of the compounding device 18. The browsersoftware 86 is installed on the data entry workstations 304 positionedin the remote data entry facilities 328A to 328D. The host data entryservice facility 326 maintains the data collection and management database 332 for the entire network. In this way, multiple order entryfacilities 328A to 328D can be linked to a single compounding facility330 via an intermediary service facility 326, which can also maintain acentral collection and management data base 332.

B. Features of the Order Entry Process Manager

FIG. 10A shows a general schematic representation of theoperator-selectable functional modules that a representativeimplementation of the order entry process manager 84 can possess. Asillustrated, these functional modules include a prescription ordermodule 400, a source solution module 402, a reports module 404, anadministration module 406, and a navigation module 408. The prescriptionorder module 400 allows an operator to enter a prescription order for agiven patient, with reference to a preexisting compound formula or to anew compound formula, as well as schedule the order for compounding. Thesource solution module 402 maintains an inventory of available basesource solutions and additive source solutions that are cross-referencedin the formula library of the prescription order module 400. The reportsmodule 404 provides an operator the capability of tracking compoundingactivities and generating various administrative reports relating tothese activities. The administration module 406 aids the operator in theperformance of various administration tasks in support of thecompounding activity. The navigation module 408 assists the operator inuse of the order entry process manager 84. Each module contains one ormore functional components that an operator can select in using themodule, as will be described in greater detail later.

A given operator can gain access to one or more of these functionalmodules, depending upon the access options that the system administratorgrants a given operator, which depends upon the functions that theoperator is required to perform. For example, a hierarchy of accessoptions can be specified for use by a physician or pharmacist, whospecifies or enters compounding orders; a compounding activityadministrator, whose function is to oversee the compounding functionfrom an administrative standpoint; and a compounding technician, whosefunction is to operate one or more compounding devices 18. The availablefunctional modules can be displayed as menu box selections on a mainscreen or home page, which opens once a given operator identifies itselfby name and assigned password on an appropriate log-on screen.

For example, FIG. 11A shows a representative main screen or home page410 for an operator who has a physician or pharmacist access option. AsFIG. 11A shows, all functional modules 400 to 408 are available forselection at this access level, because performance of that person'sfunction may require access to all features of the order entry processmanager 84. As a comparative example, FIG. 11B shows a representativemain screen or home page 410′ for a compounding technician, which offersaccess to a lesser selection of functional modules, because thetechnician's function does not require access to all the functionalfeatures of the order entry process manager 84. The functional modulemenu boxes which a given individual may access may appear in a columnalong the left side of other screens generated by the order entryprocess manager 84.

Assuming that the operator is at a physician or pharmacist access level,and is thereby viewing the home page shown in FIG. 11A, the operatorcan, with a mouse click, select a desired functional module. Assumingthe operator seeks to enter a prescription order for a given patient,the operator mouse-clicks on the Patients component of the PRESCRIPTIONORDER menu box 400, which opens the PATIENT MAIN PAGE 412 shown on FIG.11C. This window 412 provides access to the features of the Patient DataBase Component 414 of the order entry process manager 84, the functionalunits of which are shown schematically in FIG. 10B.

The Patient Data Base Component 414 allows a user to either select anexisting patient by a last name search of a list of patient informationfiles created in a patient information data base maintained by the orderentry process manager 84 (FIND A PATIENT box field 416), or by enteringthe name of a new patient (ENTER NEW PATIENT box field 418).

Upon finding an existing patient's name, the order entry process manager84 provides a window displaying the contents of the correspondingPatient Information Record 420 (FIG. 11D). The Patient InformationRecord 420 allows the operator to enter a new compounding order, basedupon previous compounding orders retained in the patient data base forthat patient (TPN ORDERS ON FILE FOR PATIENT box field 422), or allowsthe operator to enter a new compounding order for that patient basedupon a standard default templates for a patient type that the patientmatches (NEW TPN ORDER TEMPLATES AVAILABLE FOR STANDARD ADULT PATIENTTYPE box field 424).

The PRESCRIPTION ORDER MENU box 400 includes a Formula Librarycomponent. When selected, the Formula Library component provides accessto the features of the Formula Library Data Base Component 426 of theorder entry process manager 84, the functional units of which are shownschematically in FIG. 10C. Selection of the Formula Library componentopens a Formula Library web page 432 shown in FIG. 11F(1). The FormulaLibrary web page 432 permits the operator to select an existing defaultformula template for display and selection in the Patient InformationRecord page 420, or to add a new formula template for display in thePatient Information Record. Selection of template opens a scrollableOrder Template web page 434 shown in FIGS. 11F(2), 11(3), and 11F(4),that allows the operator to specify base components (types and amounts)and additive solutions (types and amounts) for a template formula.Default data in an existing template formula can also be changed andsubmitted. The Order entry process manager 84 computes the nutritionalrequirements of the template formula based upon the selected types andamounts of base components and additives, drawing upon data contained inthe source solutions module 402, as will be described in greater detaillater.

A mouse click selecting one of the order options 422 or 424 on thePatient Information Record opens a scrollable Order Entry window 436(FIGS. 11E(1) to 11E(4). The Order Entry window 436 includes field boxesthat contain details of the PRESCRIPTION ORDER (box 438), the BASECOMPONENTS included in the order (type and amount) (box 440), theADDITIVES included in the order (type and amount) (box 442), theNUTRITIONAL SUMMARY (based upon the types and amounts of the basecomponents and additives included in the order) (box 444), and the ORDERSTATUS (which will be described later) (box 446). The default listing ofsolutions and solution amounts in the BASE COMPONENTS and ADDITIVE fieldboxes 440 and 442 are provided based upon the selection on the PatientInformation Record 420 to base the order upon a previous order or astandard template. The default BASE COMPONENTS and ADDITIVES can beedited to change the previous order or template type and/or amount, orthey can be submitted without change. The Order entry process manager 84computes the NUTRITIONAL REQUIREMENTS (box 444) based upon the selectedtypes and amounts of base components and additives, drawing upon datacontained in the source solutions module 402.

The operator can open the Order Entry window (FIGS. 11E(1) to 11E(4)) toenter a compounding order for a new patient (i.e., a patient notpreviously entered into the patient data base) by selecting ENTER A NEWPATIENT field box 418 on the Patient Main Web Page 412 (FIG. 11C). Withthis selection, the order entry process manager 84 opens a windowdisplaying a New Patient web form 448 (FIGS. 11G(1) and 11G(2),prompting the operator to enter data pertaining to the new patient. Uponentry of the new patient information, the operator saves the informationto the patient data base (selecting the UPDATE field box 450—shown inFIG. 11G(2)), at which time the scrollable Order Entry window 436 opensfor entry of the compounding order (FIGS. 11E(1) to 11E(4).

The last screen of the Order Entry window 436 (FIG. 11E(4) includes anORDER STATUS box 446. The ORDER STATUS box 446 comprises a listing ofthe functional steps in a compounding operation that must be executedbetween order entry and delivery of the compounded order to a patient.The ORDER STATUS box 446 also colors or highlights the steps to indicatewhich steps have been performed and which remain to be performed. TheORDER STATUS box 446 provides a check list of functions that must beperformed to carryout the compounding process and, at a glance, informsan operator what function has been performed and what function stillneeds to be performed. In the illustrated embodiment (FIG. 11E(4)) thefunction steps listed include OPEN, SUBMITTED, AUTHORIZED, PRINTED, andCOMPOUNDED.

The OPEN step entails the opening of the Order Entry window 436, theentry of information making up the compounding order, and themouse-clicking the OPEN icon 452. In FIG. 11E(4), the OPEN icon 452 iscolored or highlighted, to indicate that this step has beenaccomplished.

The SUBMITTED step entails mouse-clicking the SUBMITTED icon 454, whichplaces the information in the database and thereby makes the Order Entrywindow containing the pending compounding order available for viewing onany workstation with a proper operator access level, which, in thiscase, would be a designated authorizing pharmacist. The SUBMITTED icon454 is colored or highlighted on the Order Entry window 436 when thestep has been completed. The order entry process manager 84 desirablykeeps track in the database of the compounding orders submitted by thevarious order entry workstations that are awaiting authorization, sothat they can be accessed in an organized fashion by the browsersoftware at the workstation of the authorizing pharmacist. Theauthorizing pharmacist knows to periodically run the browser software toaccess this queue of pending orders, to review each pending order, andindicate authorization of each order in the AUTHORIZE THIS ORDER FORCOMPOUNDING field box 456 on the Order Entry window 436.

In another arrangement, the order entry process manager 84 can include anotification function, which provides a pop-up message at theworkstation of the authorizing pharmacist to alert the individual thatthere are entered compounding orders awaiting authorization. Clicking onthe pop-up message opens a list of the orders awaiting authorizationthat the authorizing pharmacist can access.

In the illustrated embodiment, authorization entails clicking theauthorization statement (box 458), selecting the shift in which thecompounding is to be performed (box 460), and selecting the AUTHORIZEFOR COMPOUNDING icon 462. A STAT ORDER icon 464 is provided if thecompounding order is to be performed as soon as possible. The AUTHORIZEDicon 466 is colored or highlighted on the Order Entry window 436 whenthe authorization step has been completed.

The order entry process manager 84 desirably keeps track of thecompounding orders that are in the database that have been authorizedand are awaiting the printing of labeling, so that this subset of orderscan be accessed in an organized fashion at a workstation where printingoccurs. These compounding orders are accessed at the workstation wherelabeling for the final solution container 14 is to be printed.

In another arrangement, the order entry process manager 84 can include anotification function, which provides a pop-up message at theworkstation where printing occurs to alert the operator that there areauthorized compounding orders awaiting printing Clicking on the pop-upmessage opens a list of the orders awaiting label printing that theoperator can access to perform the printing function.

The order entry process manager 84 formats the labeling (see FIG. 12)based upon the information entered in the Order Entry window 436. Thelabeling includes a label 468 for the final solution container 14, aworksheet 470 identifying the source solutions and targeted compoundingvolumes, a worksheet 472 providing nutritional information for thecontents of the final solution container 14, and a label 474 for apiggyback container, if ordered. The labeling also includes the barcodes 476 that the compounding control manager 72 requires to verify thecompounding order and perform the actual compounding process. The finalcontainer bar code 476 (on the final solution container label 468) canalso be used to electronically transfer formula information aftercompounding to a capable medication dispensing device (e.g., such as aninfusion pump).

Upon completion of the printing step, the compounding order is madeavailable for electronic transfer to a compounding control manager 72 ofa compounding device 18. The PRINTED icon 478 is colored or highlightedon the Order Entry window 436 when the labeling printing step has beencompleted and the order has been made available for transfer to thecompounding control manager 72 for completion.

In the networked compounding environment that the order entry processmanager 84 makes possible, when it is time to compound, the compoundingclinician at the compounding station logs into the compounding controlmanager 72 and selects the AUTO PGM touch button 234 on the main screen202 generated by the compounding control manager 72 (see FIG. 9B). Thisopens a queue selection screen 236 (FIG. 9P), which displays a list ofpreprogrammed schedule queues that have been established by thepreviously described order entry and processing steps, as controlled bythe order entry process manager 84. The operator selects the desiredqueue (based upon the present compounding shift—e.g., morning orafternoon) and presses the ENTER touch button on the queue selectionscreen 236. The compounding control manager 72 holds the order queuelist it receives from the order entry process manager 84 in memory, andthe main screen 202 (see FIG. 9Q) thereafter allows the operator to viewthe current order queue list in the window 238. In this arrangement, theoperator selects the order from the programmed order queue list 238 onthe main screen 202, and then, as prompted by the compounding controlmanager 72, proceeds to connect the final solution container 14 to themanifold 36, perform the source solution and final solutionverifications, perform the flushing sequences (if necessary), and startscompounding in the manner previously described.

As previously described, the use of bar code data in the verificationfunction of the compounding control manager 72 necessitates that thelabeling (FIG. 12) that is generated by the order entry process manager84 must be available to and used by the compounding clinician in orderto operate the compounding device and complete the compounding order.This integrates the submission, authorization, and printing functions ofthe order entry process manager 84 with the control functions of thecompounding control manager 72.

The compounding control manager 72 communicates with the order entryprocess manager 84 when the compounding process has been completed, theCOMPOUNDED icon 480 on the Order Entry window is colored or highlightedaccordingly.

The order entry process manager 84 can provide other functions that canbe accessed through the PRESCRIPTION ORDERS menu box. For example, asshown in FIG. 11A, a Schedules component can be included that allows theoperator to view and alter the scheduling of compounding orders byshifts.

On the home screen shown in FIG. 11A, the operator can, with a mouseclick, select other functional modules of the order entry processmanager 84. If, for example, the operator seeks to view the inventory ofbase components maintained by the compounding facility, the operatormouse-clicks on the Base Components function of the SOURCE SOLUTIONSmenu box 402, which opens the BASE COMPONENTS MAIN PAGE 482 shown onFIG. 11H(1). This window provides access to the features of the BaseSolutions Data Base Component 428 of the order entry process manager 84,the functional units of which are shown schematically in FIG. 10D.

When selected, the BASE COMPONENTS MAIN PAGE 482 (FIG. 11H(1)) permitsthe operator to select a base component maintained in the existingfacility inventory, or to add a base component to the inventory.Selection of a base component opens a scrollable Base ComponentInventory Page 484 pertaining to the selected component, as shown inFIGS. 11H(2) and 11H(3). The Base Component Inventory Page 484 allowsentry and retention by the order entry process manager 84 of pertinentinformation pertaining to the selected base component—e.g., its name;family type (Amino Acid, Dextrose, Fat Emulsion, etc.); concentration;specific gravity; cost per 100 mL; the choice of the pump rotor assemblyof the compounding device to convey the component; NDC lot number;expiration date; electrolyte content, nutritional content, and otherinformation.

Similarly, if the operator seeks to access the inventory of additivesolutions maintained by the compounding facility, the operatormouse-clicks on the Additive Solutions function of the SOURCE SOLUTIONSmenu box 402, which opens the ADDITIVE SOLUTIONS MAIN PAGE 486 shown onFIG. 11I(1). This window provides access to the features of the AdditiveSolutions Data Base Component 430 of the order entry process manager 84,the functional units of which are shown schematically in FIG. 10E.

When selected, the ADDITIVE SOLUTIONS MAIN PAGE 486 (FIG. 11I(1))permits the operator to select an additive solution maintained in theexisting facility inventory, or to add an additive solution to theinventory. Selection of an additive solution opens a scrollable AdditiveSolution Inventory Page 488 pertaining to the selected additivesolution, as shown in FIGS. 11I(2) and 11I(3). The Additive SolutionInventory Page 488 allows entry and retention by the order entry processmanager 84 of pertinent information pertaining to the selected additivesolution—e.g., its solution type; its patient type; concentration;specific gravity; cost per mL; the choice of the pump rotor assembly ofthe compounding device to convey the component; NDC lot number;expiration date; electrolyte content; and other information.

The Base Solutions Data Base Component 428 and the Additive SolutionsData Base Component 430 of the order entry process manager 84 storepertinent information, for cross-reference by the other functionalmodules of the order entry process manager 84. For example, the FormulaLibrary 426 draws upon information stored in the Base Solutions DataBase 428 and the Additive Solutions Data Base 430 to fill out thedefault information in the formula templates. Thus, library solutionscan be restricted by patient type. As another example, the nutritionalinformation derived by the order entry process manager 84 contained inthe printed labeling (label 472 in FIG. 12) is drawn from informationstored in the Base Solutions Data Base 428. Administration reports (tobe described later) derive inventory, use, and cost managementinformation based upon information stored in the Base Solutions DataBase 428 and the Additive Solutions Data Base 430.

From the home page shown in FIG. 11A, the operator can, with a mouseclick, select to access the report module 404. The operator can selectamong a list of report selections contained in the REPORTS menu box 404.The reports module 404 provides an operator the capability of trackingcompounding activities and generating various administrative reportsrelating to these activities. The nature and format of the reports can,of course, vary according to the particular requirements of thecompounding facility. The reports module 404 can generate reports that,for example, (i) list the compounding orders entered during a prescribedreporting period (arranged, e.g., by patient, date, time, entryoperator, and the like); or (ii) list the compounding orders that werecompounded during a prescribed reporting period (arranged, e.g., bycompounding device number, date, time, compounding clinician, patient,final container number, time elapsed, and the like); or (iii) listsource solution usage in liters during a prescribed reporting periodarranged, e.g., by solution type, day, month, cost, and/or lot numbers,and the like; or (iv) list customer billing records for completedcompounded containers, including, e.g., costs per mL of compounded fluidby solution type, flat rates costs by container or solution type, laborcosts by machine compounding hours, flat labor costs, or a combinationof any of these; or (v) list a log of operators accessing the orderentry processing manager, arranged, e.g., by date, time, operator name,and event. Any or all of these reports can be generated by the reportsmodule 404 of the order entry process manager 84 according topreformatted templates, or by customized or relational field searches ofdata bases maintained by the order entry process manager 84. The reportsmodule 404 desirably includes the capability of formatting the reportsfor printing in hard copy format, or offloading the reports inelectronic file format, e.g., in PDF file format.

From the home page shown in FIG. 11A, the operator can, with a mouseclick, select to access the administration module 406. The operator canselect among a list of administration options contained in theADMINISTRATION menu box 406. The administration module aids theoperator, who is in this instance typically the compounding activityadministrator or supervisor, in the performance of variousadministration tasks in support of the compounding activity.

The nature of the administrative functions supported by theadministration module 406 can, of course, vary according to theparticular requirements of the compounding facility. The administrationmodule 406, for example, can allow the administrator to add, delete ormodify the schedule of shifts during which compounding takesplace—which, in turn, becomes viewable (box. 460) in the Order Entry webpage (FIG. 11E(4)), for selection by the authorizing pharmacist duringthe order authorization process. The administration module 406, asanother example, can allow the administrator to add, delete or modifythe inventory list of compounding devices maintained by the compoundingfacility—which information, in turn, becomes available for use in thecompounding reports generated by the reports module 404. Theadministration module 406, as another example, can allow theadministrator to add, delete or modify the categories of patient types(e.g., standard adult; standard neonate; standard pediatric) accountedfor by the compounding facility—which, in turn, can be linked to thepatient information data base and can also be linked to the formulatemplate data base 426 maintained by the order entry process manager 84(i.e., a standard adult formula template can be linked to a standardadult patient type, to facilitate the compound order entry process). Theadministration module 406, as another example, can allow theadministrator to add, delete or modify the list of operators by name orby operator groups (e.g., administrative staff, pharmacy staff, pharmacytechnician, supervisor) that are permitted access to the order entryprocess manager 84, as well as assign passwords and access rightsparticular to each operator and each operator group. In this respect,operator's rights and restrictions can be tailored for that operatorindividually, and not as part of an overall group (e.g., as a technicianor a pharmacist). Groups can also be prohibited or allowed access tocertain patient types (e.g., Dr. Brown cannot see information pertainingto Dr. Smith's patients).

On the home page shown in FIG. 11A, selection among the options providedby the navigation module 408 of the order entry process manager 84 canprovide a short cut to the operator's home page, a help function, ageneral data base search function outside of the order entry, report, oradministration functions, and/or a user log-out function. Selective useof operator access rights allows for patient record privacy incompliance with governmental HIPAA regulations.

As can be by now be appreciated, the order entry process manager 84 andbrowser software provide a physician or compounding order facility thecapability to electronically transfer compounding requirements to acompounding facility via direct wire, network, or internet basedsystems. The order entry process manager 84 and browser softwareprovides a compounding facility the capability to electronically entercompounding requirements on site or to receive electronically generatedcustomer compounding requirements from remote sites. The order entryprocess manager 84 and browser software provide a compounding facilitythe capability to queue multiple customer compounding requirements intoan efficient compounding and delivery schedule. The order entry processmanager 84 and browser software provide a compounding facility thecapability to generate container labels, including bar codes, as well ascontrol the actual compounding process. The order entry process manager84 and browser software provides a compounding facility the capabilityto automatically generate customer billing and inventory control forcompleted compounded containers. Billing options can include costs permL of compounded fluid by solution type, flat rates costs by bag orsolution type, labor costs by machine compounding hours, flat laborcosts, or a combination of any of these.

Features of the invention are set forth in the following claims.

1. A pharmaceutical compounding device comprising a driver, a driveshaft coupled to the driver for rotation, the drive shaft extendingalong a first axis, an idler shaft extending along a second axis offsetfrom the first axis, a peristaltic pump rotor carried on the idlershaft, a drive gear carried on the drive shaft and coupled to theperistaltic pump rotor, and a clutch assembly on the drive shaft coupledto the drive gear, the clutch assembly being operable in a first mode todisengage the drive gear from the drive shaft and a second mode toengage the drive gear with the drive shaft, to thereby selectivelyimpart rotation of the drive shaft to the peristaltic pump rotor.
 2. Adevice according to claim 1, further including a controller coupled tothe driver to control rate of rotation of the drive shaft.
 3. A deviceaccording to claim 2, wherein the controller employs PID control of thedriver.
 4. A device according to claim 3, wherein the PID controlincludes fuzzy logic.